Clearance Summary
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT received FDA 510(k) clearance under submission number K001769, sponsored by Ortho-Clinical Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-06-21.
- Submission: K001769
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2000-06-21
Classification & Regulation
This clearance is catalogued under FDA product code CGX and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.